NCT00308490

Brief Summary

The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 13, 2007

Status Verified

September 1, 2006

First QC Date

March 28, 2006

Last Update Submit

March 12, 2007

Conditions

Anemia in Chronic Renal Disease

Outcome Measures

Primary Outcomes (1)

  • Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.

Secondary Outcomes (1)

  • All iron indices' alterations during twelve weeks from the beginning of iron loading.

Interventions

iron sucroseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodialysis for three months minimum
  • stable epoetin dose for two months minimum
  • serum ferritin concentration \< 1000 ng/ml
  • transferrin saturation \< 50%
  • parathormone concentration \< 800 pg/ml

You may not qualify if:

  • hemoglobin concentration \> 13g/dl
  • serum ferritin concentration \< 20 ng/ml
  • vitamin B12 and/or folic deficiency
  • other hematologic disease than anemia
  • cancer
  • hypothyroidism
  • infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

MeSH Terms

Interventions

Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Efstathios Mitsopoulos, MD

    Papageorgiou General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

September 1, 2005

Study Completion

January 1, 2007

Last Updated

March 13, 2007

Record last verified: 2006-09

Locations

GR(1)